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US FDA grants Pfizer-BioNTech coronavirus vaccine full approval – CP24 Toronto's Breaking News

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Aug 23 (Reuters) — The U.S. Food and Drug Administration on Monday gave full approval to the COVID-19 vaccine made by Pfizer Inc and German partner BioNTech SE for use in people over the age of 16, in first such approval of a COVID-19 shot.

The vaccine has been authorized for emergency use since December and more than 204 million people in the United States have received it, based on Sunday’s data. But none of the three authorized COVID-19 vaccines had previously received full FDA approval.

Public health officials hope it will convince more unvaccinated Americans that Pfizer’s shot is safe and effective. Vaccine hesitancy among some Americans has hindered the United States response to the novel coronavirus.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” said Janet Woodcock, the U.S. Food and Drug Administration’s acting commissioner.

Roughly 51% of Americans have been fully vaccinated so far, even as a recent surge of infections spurred by the contagious Delta variant ravages parts of the country with low vaccination rates.

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Pfizer sends kids’ COVID-19 vaccine trial data to U.S. FDA – Global News

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Pfizer Inc. and BioNTech SE on Tuesday submitted initial trial data for their COVID-19 vaccine in children aged 5 to 11 and said they would make a formal request with U.S. regulators for emergency use in the coming weeks.

Coronavirus infections have soared in children, hitting their highest point in early September, according to data from the American Academy of Pediatrics.

The vaccine, which is already authorized in teens aged 12 to 15 and fully approved for ages 16 and up, induced a strong immune response in the target age group in a 2,268-participant clinical trial, the companies said on Sept. 20.


Click to play video: 'U.S. to donate half a billion additional Pfizer COVID-19 vaccines'



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U.S. to donate half a billion additional Pfizer COVID-19 vaccines


U.S. to donate half a billion additional Pfizer COVID-19 vaccines

The Pfizer-BioNTech vaccine was authorized in kids aged 12-15 roughly a month after the companies filed for authorization. If the same timeline is followed for this application, younger children could start receiving their shots as soon as late October.

A rapid authorization could help mitigate a potential surge of cases this fall, with schools already open nationwide.

While kids are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations that are more at risk of severe illness.

The companies said they plan to submit the data to the European Medicines Agency and other regulatory authorities.

Read more:
Pfizer launches large study of oral COVID-19 prevention drug

Data from the companies’ trial showed the two-shot vaccine generated an immune response in children that matched what was previously observed in 16-to-25 year olds. The safety profile was also comparable to the older age group, Pfizer said.

The drugmakers are also testing the vaccine in children aged 2-to-5 and those aged 6 months-to-2 years, with data expected in the fourth quarter.

Moderna’s COVID-19 vaccine is not yet authorized for use in adolescents in the United States, while it has gained authorization for that age group in Europe.

(Reporting by Manas Mishra in Bengaluru; Editing by Saumyadeb Chakrabarty)

© 2021 Reuters

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Trapped miners expected to emerge this morning as rescue operation continues: Vale – CP24 Toronto's Breaking News

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Liam Casey, The Canadian Press


Published Tuesday, September 28, 2021 7:54AM EDT


Last Updated Tuesday, September 28, 2021 11:14AM EDT

Thirty-three of 39 miners who were trapped underground in northern Ontario since Sunday have returned safely to the surface, the workers’ union said Tuesday as a rescue operation continued.

United Steelworkers, which represents workers trapped in Totten Mine near Sudbury, Ont., said they are pleased with the rescue operation thus far.

“A team of doctors is on site, checking workers as they emerge,” said the union, which represents 30 of the 39 staff members trapped in the mine. “No one has been physically injured in the incident or in the evacuation.”

Vale, the company that owns the mine, said it expects everyone to emerge Tuesday.

The employees were trapped in the mine on Sunday when a scoop bucket being sent underground detached and blocked the mine shaft, Vale said.

As a result, it said the “conveyance system” for taking workers to and from the surface became unavailable.

Vale said the trapped miners have been staying in underground “refuge stations,” some 900 to 1,200 metres underground, as part of the company’s standard procedures.

The workers began making their way out Monday night through a “a secondary egress ladder system,” the company said.

“We thank the impacted employees for their patience and perseverance and the mine rescue teams for their tireless dedication and support,” said Gord Gilpin, head of mining for Vale’s Ontario operations. “This has been an incredible team effort.”

A rescue team met the miners Monday and prepared them for the long journey to the surface.

The union said the miners had to scale a system of ladders, with each ladder being about six metres long and with a staging area at every break.

“When an incident like this unfortunately happens, everyone comes together,” said Nick Larochelle, president of USW Local 6500

“The miners support each other, the highly trained mine rescue teams come together and the whole community waits patiently praying for the safe return of every one of the 39 miners to surface.”

The company said the trapped miners had access to food, water and medicine. The union added that miners had been able to make phone calls to both communicate with rescuers and to call loved ones.

Totten Mine opened in 2014, in Worthington, Ont., and produces copper, nickel and precious metals. It employs about 200 people.

The province’s Ministry of Labour, Training and Skills Development, said an inspection team will investigate the incident once the rescue operation is finished.

This report by The Canadian Press was first published Sept. 28, 2021.

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33 trapped miners safe after rescue, 6 more on long trek out of mine near Sudbury – CP24 Toronto's Breaking News

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Liam Casey, The Canadian Press


Published Tuesday, September 28, 2021 7:54AM EDT


Last Updated Tuesday, September 28, 2021 11:14AM EDT

Thirty-three of 39 miners who were trapped underground in northern Ontario since Sunday have returned safely to the surface, the workers’ union said Tuesday as a rescue operation continued.

United Steelworkers, which represents workers trapped in Totten Mine near Sudbury, Ont., said they are pleased with the rescue operation thus far.

“A team of doctors is on site, checking workers as they emerge,” said the union, which represents 30 of the 39 staff members trapped in the mine. “No one has been physically injured in the incident or in the evacuation.”

Vale, the company that owns the mine, said it expects everyone to emerge Tuesday.

The employees were trapped in the mine on Sunday when a scoop bucket being sent underground detached and blocked the mine shaft, Vale said.

As a result, it said the “conveyance system” for taking workers to and from the surface became unavailable.

Vale said the trapped miners have been staying in underground “refuge stations,” some 900 to 1,200 metres underground, as part of the company’s standard procedures.

The workers began making their way out Monday night through a “a secondary egress ladder system,” the company said.

“We thank the impacted employees for their patience and perseverance and the mine rescue teams for their tireless dedication and support,” said Gord Gilpin, head of mining for Vale’s Ontario operations. “This has been an incredible team effort.”

A rescue team met the miners Monday and prepared them for the long journey to the surface.

The union said the miners had to scale a system of ladders, with each ladder being about six metres long and with a staging area at every break.

“When an incident like this unfortunately happens, everyone comes together,” said Nick Larochelle, president of USW Local 6500

“The miners support each other, the highly trained mine rescue teams come together and the whole community waits patiently praying for the safe return of every one of the 39 miners to surface.”

The company said the trapped miners had access to food, water and medicine. The union added that miners had been able to make phone calls to both communicate with rescuers and to call loved ones.

Totten Mine opened in 2014, in Worthington, Ont., and produces copper, nickel and precious metals. It employs about 200 people.

The province’s Ministry of Labour, Training and Skills Development, said an inspection team will investigate the incident once the rescue operation is finished.

This report by The Canadian Press was first published Sept. 28, 2021.

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